PRESS 
    RELEASE 
      
    UTMD Responds to On-going Customer Questions Prompted by Competitors  
    
    October
    12, 2004 
    Contact: Paul Richins  
    (801) 566-1200  
    “The reports of my death are greatly 
    exaggerated.” …Mark Twain 
     
    Salt Lake City, Utah – In August, Utah Medical Products, Inc. (Nasdaq:UTMD) 
    published a number of its own press releases in response to an August 10, 
    2004 press release from the U.S. Food & Drug Administration (FDA) which has 
    unfairly caused some concern regarding the continued use of UTMD’s products. 
    UTMD would like to remind shareholders, customers and others that they can 
    conveniently find these press releases stating UTMD’s position by accessing
    www.utahmed.com on the Internet. 
     
    Unfortunately, UTMD’s competitors, instead of appreciating that UTMD is also 
    challenging systemic deficiencies within the government that affect 
    responsible manufacturers in the device industry, have tried to take 
    advantage of the situation through innuendo to customers that UTMD may be 
    imminently shut down. This is false, as explained in more detail below.  
     
    In order to defend the interest of its stakeholders, not the least of whom 
    are patients that should not be denied UTMD’s unique life-saving products, 
    UTMD wishes to refresh its position: 
    
      - Two months after the FDA press release, 
      UTMD continues to manufacture and distribute all of its products worldwide 
      without any regulatory restriction.
 
      - There has been no mandated recall or 
      any other regulatory enforcement action that restricts customers from 
      using UTMD’s products.
 
      - There has not been, and is not now, any 
      allegation by the FDA that UTMD’s products are not safe or effective.
 
      - There is no FDA claim of defective 
      products or products not conforming to specifications.
 
      - The proven extremely low product 
      liability risk using UTMD’s products has not changed.
 
     
    The FDA, after completing four comprehensive 
    inspections of UTMD’s internal quality system in three years, requested an 
    injunction that would halt production and distribution while the company 
    fixes alleged “violations” which have not yet been proven. UTMD, supported 
    by a variety of independent respected experts after evaluating its 
    manufacturing practices, vehemently denies that there are violations of the 
    Quality System Regulation (QSR). UTMD seeks to confirm decades of successful 
    device manufacturing against a paper-driven FDA.  
     
    The FDA-483 forms submitted by inspectors after each inspection contain 
    “observations” which are not, according to the FDA’s own policies, 
    considered “violations” by the agency until reviewed by superiors and linked 
    to provisions of the QSR. (See The Wall Street Journal, 9/29/04, “FDA Is 
    Questioned on Report About Red Cross Unit in Atlanta.”) Since this dispute 
    began in 2001, no reviewer or superior from the FDA has ever identified or 
    discussed with UTMD what is inadequate about any of UTMD’s detailed written 
    responses to FDA-483 observations, or any QSR linkages. The FDA-483 
    observations regarding UTMD’s documentation, remarkably, changed 
    substantially from inspection to inspection without any significant changes 
    made by UTMD. In the latest 2004 inspection by three inspectors over a five 
    week time span, the number of FDA-483 observations declined dramatically 
    from the previous 2003 inspection, and those relating to sterilization 
    disappeared without any change to UTMD procedures.  
     
    A U.S. Federal Court in Salt Lake City will decide if the FDA’s request for 
    injunction has any merit. The Court has set a schedule for discovery which 
    will lead to a trial, if it happens at all, no earlier than June 2005. Any 
    reference to an imminent shut down of UTMD is obviously false. 
     
    The paradox for UTMD’s customers that is being unscrupulously exploited by 
    competitors is “How could this (the FDA’s press release that UTMD is 
    violating the QSR) not be true?” UTMD asks other parties to consider whether 
    the FDA is always right in what it does. Interestingly, the FDA has not 
    sought a preliminary injunction against UTMD, which would be in the public 
    interest if there were a device quality issue. This appears to be virtually 
    unprecedented in a case where they seek such severe action against a 
    company. It is also interesting that the FDA appears to be in no hurry to 
    have their claims adjudicated, given they first requested a trial date in 
    August 2005. Before we arrive at the point in time for a trial, UTMD 
    believes there will be other public information that will reassure customers 
    that an interruption in distribution of UTMD’s products will not happen. 
     
    Investors are cautioned that this press release contains forward looking 
    statements and that actual events may differ from those projected.  
     
    Utah Medical Products, Inc., with particular interest in health care for 
    women and their babies, develops, manufactures, assembles and markets a 
    broad range of disposable and reusable specialty medical devices designed 
    for better health outcomes for patients and their care-providers. For more 
    information about Utah Medical Products, Inc., visit UTMD’s website at
    www.utahmed.com. 
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